FDA EIR - Ramy Joseph Toma, M.D. - February 29, 2024

An FDA inspection of clinical investigator Ramy J. Toma, M.D., in Birmingham, AL, was conducted from February 20-29, 2024. This comprehensive surveillance, pre-announced inspection, performed under regulatory framework CP 7348.811, identified a primary violation documented in an FDA-483. The main issue observed was a failure to promptly report serious adverse events (SAEs) to the study sponsor, as mandated by 21 CFR 312.64(b) and the study protocol. Thirteen SAEs were not reported within the required 24-hour timeframe, with instances showing delays of weeks to months. The inspection also noted some under-reporting of adverse events and concomitant medications. Prior to this FDA visit, the Institutional Review Board had reported instances of non-compliance involving a research assistant falsifying subject safety calls, which Dr. Toma had previously addressed with a corrective action plan. In response to the FDA observation, Dr. Toma acknowledged the findings, stating he had addressed the reporting issue with his staff and would implement corrections. He committed to retraining staff on Good Clinical Practice (GCP) and Good Documentation Practice (GDP) to ensure accurate, legible, contemporaneous, original, and attributable (ALCOA) source documentation and timely data entry. A written response to the FDA-483 is required within 15 business days.